Methods and Systems for Treating Intracranial Hypertension and Related Indications Using An Optic Nerve Stent or Shunt

ABSTRACT

Embodiments of the present specification provide surgical methods and apparatuses to deploy at least one stent through an optic nerve sheath in order to maintain an opening/fenestration for intracranial fluid egress. The surgical method creates a fenestration, an opening, a slit, or a hole, through an optic nerve sheath of a human patient. The fenestration is created in a minimally invasive manner using an applicator, such as an endoscopic visualization apparatus, that includes a stent or shunt for deploying through the fenestration. The presently disclosed specification is indicated to treat papilledema and/or intracranial hypertension and to deliver therapeutic compositions through the optic nerve sheath.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S. patent applicationSer. No. 15/690,599, entitled “Methods and Systems for TreatingIntracranial Hypertension and Related Indications Using an Optic NerveStent or Shunt” and filed on Aug. 30, 2017, which relies on, forpriority, U.S. Patent Provisional Application No. 62/381,608, of thesame title and filed on Aug. 31, 2016; U.S. Patent ProvisionalApplication No. 62/443,931, of the same title and filed on Jan. 9, 2017;and U.S. Patent Provisional Application No. 62/457,524, of the sametitle and filed on Feb. 10, 2017.

The above-mentioned applications are herein incorporated by reference intheir entirety.

FIELD

The present specification generally relates to methods and devices fortreatment of intracranial pressure, and particularly to a microsurgicalstent-type devices and associated methods for treatment of intracranialpressure.

BACKGROUND

Intracranial Hypertension (IH) relates to a neurological disorder thatis characterized by increased intracranial pressure (ICP) arising fromfluid pressure around the brain. The condition occurs when the pressureof the cerebrospinal fluid in the subarachnoid space (SAS), which is thespace between the brain and the skull, increases above a normal range.Prolonged exposure to this condition often results in optic discswelling, also known as papilledema, and subsequent damage to the opticdisc, leading to a loss of vision.

While, in some patients, IH can be treated medically with the use of anICP lowering agent such as acetazolamide and a weight-reduction program,surgical treatment is warranted for those patients who are experiencingvision loss, cannot tolerate medical therapy and/or develop progressivesymptoms despite maximal medical treatment. Specifically, patients whocannot tolerate medical therapy or develop progressive symptoms despitemaximal medical treatment undergo cerebrospinal fluid diversionprocedures.

For those patients who are receiving maximal medical therapy and yethave progressive visual loss or impending visual loss with minimal ortolerable headaches, an optic nerve sheath fenestration (ONSF) procedureis warranted. ONSF releases the build-up of intracranial fluid andlowers intracranial pressure by providing an outflow window through theoptic nerve sheath. It is believed that an opening within the opticnerve sheath will allow for a sudden and sustained drop in the SASpressure and relief of edema in and around the optic nerve head andoptic disc. The fenestration is done by accessing the retrobulbarsection of the optic nerve and creating a slit in the sheath.

The three conventional surgical approaches for ONSF are superior eyelid,lateral orbital, and medial transconjunctival.

Superior Eyelid Approach: The medial intraconal space is accessedthrough a superomedial eyelid crease incision. The orbital septum isopened and the medial horn of the levator aponeurosis is pushedlaterally. With blunt dissection, a plane is created between the medialrectus muscle and the superior oblique tendon to access the posteriororbit avoiding the superior ophthalmic vein and vortex veins. Withfurther posterior dissection, the optic nerve comes into view and a slitor rectangular window is created within the optic nerve sheath.Limitations of this approach include an increased distance from incisionsite to the optic nerve and an external (skin) incision.

Lateral Orbital Approach: The procedure begins with an en bloc removalof the lateral orbital wall. The periorbita is incised in a T-shapedfashion and blunt dissection of the perimuscular fascial sheaths isperformed until the lateral rectus muscle is identified. A tractionsuture is placed under the insertion of the lateral rectus muscle andthe suture is anchored medially, adducting the eye in order to move theoptic nerve laterally. Dissection with specially designedorbital-neurosurgical brain retractors is used to gain access to theoptic nerve. Once the retrobulbar portion of the optic nerve isadequately exposed, an operating microscope is used to assist in awindow incision of the optic nerve sheath. The periorbita is closed withinterrupted sutures and the bone fragment is re-approximated to thelateral orbital wall using a nonabsorbable suture. Limitations of thisapproach include longer operating time, an external incision, and a morecomplex surgical procedure that requires removal of the orbital rim.

Medial Transconjunctival Approach: A medial limbal conjunctival peritomyis performed and the conjunctiva incision is extended superiorly andinferiorly. The medial rectus muscle is isolated and the tendon issecured with a double armed 6-0 vicryl suture. The muscle is detachedfrom the globe using scissors, leaving a small remnant of muscle tendonattached to the globe. A 5-0 Dacron traction suture is placed throughthe muscle tendon, and the globe is retracted laterally. The longposterior ciliary arteries are then identified between the superior andinferior poles of the insertion of the medial rectus muscle. With theaid of small malleable retractors the retrobulbar optic nerve isapproached through the posterior reflection of Tenon's capsule andretrobulbar orbital fat. The orbital fat is retracted away from theoptic nerve with small strips of cottonoids. A small angled forceps isused to improve exposure of the optic nerve. With the assistance of theoperating microscope a sharp blade on a long handle is used to incisethe optic nerve sheath approximately 2 mm posterior to the globe withcareful attention to avoid any blood vessels on the surface of thenerve. A fine toothed forceps is inserted into the incision site andextended posteriorly with microscissors to a total length of 3-5 mm. Atenotomy hook may be inserted into the SAS and moved in theanterior-posterior direction to lyse any arachnoidal trabeculations andadhesions. On completion of the fenestration, the traction suture isremoved, and the medial rectus is reattached to the globe using standardstrabismus muscle technique. The conjunctiva is closed with 8-0 vicrylsutures. An antibiotic-steroid ointment is applied to the eye and aprotective shield is placed over the eye to prevent any direct externalpressure.

Current procedures are not effective due to variability of the slit andthe healing response which leads to closure and an increase in thepressure. It is believed that nearly 50% of the surgeries requirerevision in a few years. Furthermore, ONSF can be associated with bothminor and profound ocular complications. In a review of the publishedliterature, the complication rate of ONSF was found to range broadlybetween 4.8-45% with a mean of 12.9%. In the same review of 317 cases ofONSF, 13% of cases were deemed a failure, which was defined asprogressive visual loss despite the surgery or need for reoperation. Inaddition, case reports have described patients with progressive visualloss after ONSF due to sustained elevated ICP.

Furthermore, existing methods of optic nerve decompression requirecomplex and invasive surgical procedures that are further complicated bythe lack of easy access to the optic nerve which is behind the globe andhas minimal surgical exposure. The surgery is normally performed in thehospital operating room and requires cutting vital ocular tissuesincluding complete sectioning and subsequent reattachment of the musclesof the eye to expose and visualize the optic nerve sheath.

What is needed is an approach to optic nerve fenestration that is notsurgically complex, avoids an external (skin) incision, and safelyprovides for the on-going release of intracranial fluid and/or on-goinglowering of intracranial pressure and for deliverance of a therapeuticagent in the CSF and/or subconjunctival space of a patient.

What is also needed are novel stents and/or shunts which are speciallydesigned for this particular surgical approach and that, when implanted,achieve the on-going release of intracranial fluid and/or on-goingdecrease of intracranial pressure and for deliverance of a therapeuticagent in the CSF and/or subconjunctival space of a patient.

SUMMARY

The following embodiments and aspects thereof are described andillustrated in conjunction with systems, tools and methods, which aremeant to be exemplary and illustrative, not limiting in scope.

The present specification discloses a surgical method for treating atleast one of intracranial hypertension and papilledema in a patient,comprising: navigating an applier device along a curvature of an eye ofthe patient without removing a medial rectus muscle associated with saideye; injecting a viscoelastic between the sclera of said eye and aTenon's capsule associated with said eye; inserting at least one stentinto an optic nerve sheath associated with the eye; observing an amountof fluid egress from the at least one stent; and removing theviscoelastic.

Optionally, the method further comprises creating a conjunctival accessbehind said eye. Optionally, the method comprises performing at leastone of a medial peritomy on said eye prior to injecting saidviscoelastic and a conjunctival incision on said eye prior to injectingsaid viscoelastic. The medial peritomy may be performed in a directionfrom 12 o'clock to 6 o'clock. Optionally, the method comprisesperforming a conjunctival incision.

Optionally, the method further comprises dissecting bluntly to bare thesclera prior to injecting said viscoelastic. The dissecting may beperformed with Westcott scissors.

Optionally, the method further comprises isolating the medial rectusmuscle prior to injecting said viscoelastic.

Optionally, the method further comprises identifying an insertion siteon an optic nerve associated with the eye. The insertion site may be ata distance of at least 1.5 mm from a globe of said eye. Optionally, themethod comprises inserting the at least one stent at the insertion site,wherein said insertion site is at least 1.5 mm posterior to the opticnerve.

Optionally, the method comprises inserting the at least one stent havinga length between 3 mm and 6 mm. The method may comprise inserting the atleast one stent having a diameter of 6 mm or less.

Optionally, the at least one stent comprises material with propertiesthat are a combination of one or more of: bio-degradable,heparin-coated, non-ferromagnetic Titanium, polyamide, super-elastic,bio-compatible, an alloy of Nickel-Titanium, rigid, flexible,expandable, and non-expandable.

Optionally, the at least one stent has as an elongated tube. The atleast one stent may have a flat structure.

Optionally, the at least one stent shaped is J shaped, wherein a longerside of the J-shaped stent is longitudinally placed within the opticnerve sheath, and the curved, shorter side maintains an opening to anoutside of said optic nerve sheath.

Optionally, the at least one stent further comprises one or moresensors.

Optionally, the at least one stent further comprises one or moretherapeutic compositions.

Optionally, the method further comprises inspecting the site ofinserting for fluid egress.

Optionally, the method further comprises removing the viscoelastic byaspirating.

The present specification also discloses a method of loweringintracranial pressure of a patient by maintaining an opening forintracranial fluid egress through an optical sheath of the patient, themethod comprising: creating a conjunctival access in the patient's eye;navigating an applier device along a curvature of an eye of the patientwithout removing a medial rectus muscle associated with said eye;inserting at least one stent into the optic nerve sheath associated withthe eye by using the applier device; and monitoring an amount of fluidegress from the at least one stent lowering intracranial pressure to adesired value.

Optionally, the method further comprises injecting a viscoelasticbetween the sclera of said eye and a Tenon's capsule associated withsaid eye; and removing the viscoelastic after fluid egress from the atleast one stent.

Optionally, the method further comprises injecting an irrigation fluidbetween the sclera of said eye and a Tenon's capsule associated withsaid eye.

Optionally, the shunt comprises at least one sensor located at aningress tip of the shunt. The sensor may be a MEMS sensor configured tomeasure intracranial pressure and to monitor fluid flow rates.

Optionally, the applier device comprises a curved applier coupled with ahandle portion for extending and retracting the curved applier, with aradius of curvature of the curved applier ranging from 3 mm to 50 mm forfacilitating navigation along the curvature of the eye. The applierdevice may be an endoscopic device comprising one or more illuminationelements, and at least one endoscopic viewing element for visualization.

The present specification also discloses a method of delivering atherapeutic agent into one of a cerebral spinal fluid (CSF) and asubconjunctival space of a patient via a drug delivery device implantedin an optic nerve sheath of the patient, the drug delivery devicecomprising at least a reservoir containing the therapeutic agent coupledwith a one-way valve and an outlet tube, the method comprising: creatinga conjunctival access in the patient's eye; navigating an applier devicealong a curvature of an eye of the patient without removing a medialrectus muscle associated with said eye; identifying the optic nerve andcorresponding insertion site in said eye; inserting the drug deliverydevice into the identified insertion site in the optic nerve; anddelivering the therapeutic agent from the reservoir into the insertionsite via the outlet tube.

Optionally, the method further comprises injecting a viscoelasticbetween the sclera of said eye and a Tenon's capsule associated withsaid eye; and removing the viscoelastic after inserting the drugdelivery device into the identified insertion site.

Optionally, the one-way valve comprises a flexible membrane folded todefine a chamber therebetween, the membrane being coupled with thereservoir and the outlet tube for delivering the therapeutic agent fromthe reservoir into the outlet tube.

Optionally, the reservoir is one of: a refillable subconjunctival,subtenon, ocular and extra ocular reservoir, the reservoir beingconnected into an extended optic nerve subdural space of the patient andbeing re-fillable for a plurality of drug administrations.

Optionally, the outlet tube comprises a uni-directional valve forallowing the therapeutic agent to flow from the reservoir towards thepatient's eye under low pressure gradient conditions, while preventingretrograde flow back towards the reservoir.

The present specification also discloses a drug delivery device fordelivering a therapeutic agent into one of a cerebral spinal fluid (CSF)and a subconjunctival space of a patient, the drug delivery devicecomprising: a stent, wherein the stent has a lumen extendingtherethrough and is J shaped, wherein a longer side of the J-shapedstent is configured to be longitudinally placed within an optic nervesheath of the patient, and wherein the curved, shorter side of theJ-shaped stent maintains an opening to an outside of the optic nervesheath; and a reservoir in fluid communication with the stent, whereinthe reservoir contains the therapeutic agent and is coupled with anoutlet tube via a one-way valve.

The stent may have a length between 3 mm and 6 mm.

The stent may have an outer diameter of 6 mm or less.

Optionally, the stent comprises material with properties that are acombination of one or more of: bio-degradable, heparin-coated,non-ferromagnetic Titanium, polyamide, super-elastic, bio-compatible, analloy of Nickel-Titanium, rigid, flexible, expandable, andnon-expandable.

Optionally, the stent comprises an elongated tube.

Optionally, the stent has a flat exterior structure.

Optionally, the one-way valve comprises a flexible membrane that isfolded to define a chamber wherein the membrane is coupled with thereservoir and the outlet tube for delivering the therapeutic agent fromthe reservoir into the outlet tube.

Optionally, the reservoir is at least one of a refillablesubconjunctival reservoir, subtenon reservoir, ocular reservoir andextra ocular reservoir wherein the reservoir is configured to beconnected into an extended optic nerve subdural space of the patient andconfigured to be re-fellable for a plurality of drug administrations.

Optionally, the outlet tube comprises a unidirectional valve forallowing the therapeutic agent to flow from the reservoir towards theeye under low pressure gradient conditions, while preventing retrogradeflow back towards the reservoir. The unidirectional valve may be in awet-straw configuration wherein a proximal end of a lumen of theunidirectional valve that is coupled to the reservoir is broader than adistal end of the lumen delivering the therapeutic agent into theinsertion site. The unidirectional valve may be made of TEFLON.

The present specification also discloses a drug delivery device fordelivering a therapeutic agent into one of a cerebral spinal fluid (CSF)and a subconjunctival space of a patient, the drug delivery devicecomprising: a stent, wherein the stent has a lumen extendingtherethrough and is L shaped, wherein a longer side of the L-shapedstent is configured to be longitudinally placed within an optic nervesheath of the patient, and wherein the curved, shorter side of theL-shaped stent maintains an opening to an outside of the optic nervesheath; and a reservoir in fluid communication with the stent, whereinthe reservoir contains the therapeutic agent and is coupled with anoutlet tube via a one-way valve.

The stent may have a length between 3 mm and 6 mm.

The stent may have an outer diameter of 6 mm or less.

Optionally, the stent comprises material with properties that are acombination of one or more of: bio-degradable, heparin-coated,non-ferromagnetic Titanium, polyamide, super-elastic, bio-compatible, analloy of Nickel-Titanium, rigid, flexible, expandable, andnon-expandable.

Optionally, the one-way valve comprises a flexible membrane that isfolded to define a chamber wherein the membrane is coupled with thereservoir and the outlet tube for delivering the therapeutic agent fromthe reservoir into the outlet tube.

The aforementioned and other embodiments of the present specificationshall be described in greater depth in the drawings and detaileddescription provided below.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other features and advantages of the present specificationwill be appreciated, as they become better understood by reference tothe following detailed description when considered in connection withthe accompanying drawings, wherein:

FIG. 1A illustrates a general layout of a region on the side of a face,and behind an eyeball of an eye in an orbit, as may be viewed from topwhile looking into orbit after top of the skull is removed;

FIG. 1B illustrates another view of eyeball connected to optic nerve;

FIG. 2 illustrates a general layout of a region behind the globe of theeye that includes an optic nerve;

FIG. 3A illustrates an exemplary process for implanting a shunt or stentin the optic nerve sheath;

FIG. 3B illustrates a stent-type drug delivery device implanted into theoptic nerve sheath, in accordance with an embodiment of the presentspecification;

FIG. 4A is a perspective view of a stent or shunt, in accordance with anembodiment of the present specification;

FIG. 4B is a perspective view of a stent or shunt, in accordance withanother embodiment of the present specification;

FIG. 5A illustrates a stent or shunt carrying an optional sensor andpositioned within an optic nerve sheath, in accordance with anembodiment of the present specification;

FIG. 5B illustrates a sensor positioned within the optic nerve sheathwithout a stent or shunt, in accordance with an embodiment of thepresent specification;

FIG. 6A shows a perspective view of an exemplary drug delivery device orvalve in accordance with an embodiment of the present specification;

FIG. 6B is an exploded view of an exemplary drug delivery device of FIG.6A, in accordance with an embodiment of the present specification;

FIG. 6C is a cross-sectional illustration of an outlet tube of the drugdelivery device of FIG. 6A including a unidirectional valve, inaccordance with an embodiment of the present specification;

FIG. 6D is a flowchart illustrating a method of surgical implantation ofthe drug delivery device 600, in accordance with an embodiment of thepresent specification; and,

FIG. 7 is a perspective view of a stent applicator or delivery system,in accordance with an embodiment of the present specification.

DETAILED DESCRIPTION

In an embodiment, a surgical method and apparatus is provided to deployat least one stent through an optic nerve sheath in order to maintain anopening for intracranial fluid egress. In an embodiment, the surgicalmethod creates a fenestration, a slit, access point, cavity, or a hole(collectively “opening” or “fenestration”) through an optical sheath ofa human patient. The fenestration is created in a minimally invasivemanner using an applicator, such as an endoscopic visualizationapparatus, that includes a micro-stent or micro-shunt for deployingthrough the fenestration. In an embodiment, the applicator passesthrough the conjunctiva to access the retrobulbar space of the subjectand implants the micro-stent through the optical sheath. In otherembodiments, the applicator passes through Tenon's, or any other partwithin the anatomy of the eye that allows access to the retrobulbarspace.

Intracranial pressure (ICP) refers to the pressure inside the skull andthus in brain tissue and cerebrospinal fluid (CSF). ICP is measured inmillimeters of mercury (mmHg), centimeters of water/CSF (cm H₂O/CSF) ormillimeters of water/CSF (mm H₂O/CSF) and, at rest, is normally 7-15mmHg for a supine adult.

Intracranial hypertension, commonly abbreviated IH, IICP or raised ICP,refers to elevated pressure in the cranium. IH is defined as ICP>20 mmHg (26 cm H₂O). At ICP of 20-25 mm Hg, the upper limit of normal,treatment to reduce ICP may be needed. It should be appreciated thatthere are slight deviations in normal pressure ranges and upper limitsbetween adults and children, with the same being true regarding upperlimits of normal and among people with larger body mass indexes (BMIs),depending on the disease or condition. For example, for IdiopathicIntracranial Hypertension, elevated lumbar puncture opening pressureis >250 mm H₂O/CSF in adults and >280 mm H₂O/CSF in children (250 mmH₂O/CSF if the child is not sedated and not obese) in a properlyperformed lumbar puncture.

The present specification is directed towards multiple embodiments. Thefollowing disclosure is provided in order to enable a person havingordinary skill in the art to practice the invention. Language used inthis specification should not be interpreted as a general disavowal ofany one specific embodiment or used to limit the claims beyond themeaning of the terms used therein. The general principles defined hereinmay be applied to other embodiments and applications without departingfrom the spirit and scope of the invention. Also, the terminology andphraseology used is for the purpose of describing exemplary embodimentsand should not be considered limiting. Thus, the present invention is tobe accorded the widest scope encompassing numerous alternatives,modifications and equivalents consistent with the principles andfeatures disclosed. For purpose of clarity, details relating totechnical material that is known in the technical fields related to theinvention have not been described in detail so as not to unnecessarilyobscure the present invention. In the description and claims of theapplication, each of the words “comprise” “include” and “have”, andforms thereof, are not necessarily limited to members in a list withwhich the words may be associated.

It should be noted herein that any feature or component described inassociation with a specific embodiment may be used and implemented withany other embodiment unless clearly indicated otherwise.

FIG. 1A illustrates a general layout of a region on the side of a face102, and behind an eyeball 104 of an eye in an orbit 106, as may beviewed from top while looking into orbit 106 after top of the skull isremoved. Eyeball 104 is located just above nose 108. Eyeball 104 isconnected to an optic nerve 110. The diameter of the optic nerve 110increases from about 1.6 mm within eyeball 104 to 3.5 mm in orbit 106 to4.5 mm within the cranial space. Optic nerve 110 component lengths are 1mm in eyeball 104, 24 mm in orbit 106, 9 mm in the optic canal, and 16mm in the cranial space before joining the optic chiasm. Partialdecussation occurs in the optic chiasm, and about 53% of the fiberscross to form the optic tracts. Most of these fibers terminate in thelateral geniculate body. Based on this anatomy, optic nerve 110 may bedivided in four parts as indicated in FIG. 1A and described in series,as it courses from eyeball 104 to an optic chiasm. The segments include:Optic Nerve Head (1), where optic nerve 110 begins in eyeball 104 withfibers from retina, Intraorbital Optic Nerve (2), the part of opticnerve 110 that lies within orbit 106, Intracanalicular Optic Nerve (3),the part within a bony canal known as the optic canal, and IntracranialOptic Nerve (4), the part within a cranial cavity, which ends at theoptic chiasm.

The first segment of optic nerve 110 is the optic nerve head (ONH)located at the insertion of the nerve into the eye. The ONH representsthe convergence of approximately 1.2 million axons of the retinalganglion cells (RGCs). The ONH, which measures 1 mm in length and 1.5 mmin diameter, is represented by a physiologic blind spot on perimetrytesting and is located approximately 4 mm nasal from the center of themacula (i.e. fovea). The ONH receives its blood supply from the circleof Zinn-Haller and the posterior ciliary arteries, which are branches ofthe ophthalmic artery.

The second segment of optic nerve 110 is the intraorbital optic nerve.At the ONH, the unmyelinated axons of a retinal nerve fiber layer (RNFL)make a 90° turn to exit the eye. The lamina cribrosa, a distinct regionof the sclera consisting of stacks of fenestrated sheets of elasticfibers and connective tissue, allows the passage of the optic nerveaxons from the eye into the retrobulbar orbital space. After passingthrough the lamina cribrosa, the axons become covered by myelin derivedfrom oligodendrocytes. The presence of myelin increases the diameter ofthe intraorbital optic nerve to approximately 3 mm. Posterior to andcontinuous with the sclera, optic nerve 110 procures a dural sheath (ofsheath 228), in addition to the arachnoid mater and pia mater. A uniqueanatomical feature of the intraorbital optic nerve is the fact that itslength (28 mm) is nearly double the distance from the back of the eye tothe orbital apex (15 mm). This configuration allows for the globe tofreely rotate within the orbit and to compensate for any pathologicaxial shifts within the orbit without causing visual dysfunction. Theblood supply of the intraorbital optic nerve is derived from the pialnetwork of vessels from the ophthalmic artery.

The intracanalicular optic nerve is the third segment of optic nerve110, and begins at the point where optic nerve 110 enters the opticcanal. At the orbital apex, the dura mater covering optic nerve 110fuses with the periorbita of the orbit. It is also at this location thatoptic nerve 110 is encircled by the annulus of Zinn represented by thetendinous insertions of the four recti muscles. The intracanalicularportion of the optic nerve is anchored within the optic canal, whichmeasures approximately 8-10 mm in length and 5-7 mm in width. Theintracanalicular optic nerve represents a watershed zone because it hasa dual vascular supply, anteriorly from branches of the ophthalmicartery and posteriorly from small vessels arising from the internalcarotid artery and the superior hypophyseal artery.

The fourth segment of optic nerve 110 is the intracranial optic nerve.Optic nerve 110 enters the cranial vault underneath the anterior clinoidprocess and over the ophthalmic artery. Upon exiting the optic canal,the dura of the optic nerve fuses with the periosteum of the middlecranial fossa. The nerve then travels a variable distance, ranging from8-12 mm, before joining the optic chiasm. The intracranial optic nerveis supplied by branches from the internal carotid artery, the superiorhypophyseal artery, anterior cerebral artery, and anterior communicatingartery.

FIG. 1B illustrates another view of eyeball 104 connected to optic nerve110. In the figure, optic nerve 110 is seen travelling between at leasttwo muscles in orbit 106—an inferior rectus muscle 112 and a medialrectus muscle 114.

FIG. 2 illustrates a general layout of a region behind globe of the eyethat includes an optic nerve 210. In the figure, optic nerve 210 isshown under elevated pressure resulting from increase in pressure ofcerebrospinal fluid 226. An optic nerve sheath 228 is a layer of tissuethat closely envelopes optic nerve 210 such that cerebrospinal fluid 226occupies the space between optic nerve 210 and sheath 228. Optic sheath228 includes three meningeal membranes—dura mater, arachnoid mater, andpia mater—that cover optic nerve 210.

Optic nerve 210 is a central nervous system (CNS) white matter tract. Asa result of this common lineage between optic nerve 210 and the CNS, theSAS of optic nerve 210 is contiguous with the SAS of the brain. Thearachnoid membrane of optic nerve 210, which functions to support andprotect the underlying axons, is continuous with the arachnoid membraneof the subdural intracranial space and allows for the free circulationof cerebrospinal fluid (CSF) 226 around optic nerve 210 and brain.

By virtue of the fact that optic nerve sheath 228 serves as a CSFconduit between the brain and the eye, pathology involving the contentsof the cranium can lead to pathology of the ONH. As discussed above, CNSpathology may be characterized by increased ICP, including intracranialmasses, infectious diseases, inflammatory diseases, and IH, can impactthe ONH, both structurally and functionally. When raised ICP istransmitted to the SAS within optic nerve sheath 228, ONH edema ensues,with papilledema being the first ophthalmoscopic sign of raised ICP.Investigations examining the pathophysiology of papilledema have shownaxonal swelling at the ONH. Nerve fiber dysfunction due to axonalswelling can result in loss of central vision, a decrease in peripheralvision, and, ultimately, optic atrophy.

Accordingly, in accordance with another aspect, a plurality of drugs maybe delivered to the CSF/brain through the optic nerve sheath using animplantable drug delivery device, particularly where antibiotics,biologics, and other therapeutics may otherwise have a low brainbioavailability when administered orally (PO) or intravenously (IV).Treatments of conditions/diseases, through CSF delivery of therapeutics,comprise hematologic/oncologic conditions, including primary tumors,secondary tumors, metastasis or inflammatory conditions that requiredrug deliver via cerebral spinal fluid.

Surgical Method for Treatment of IH

In one embodiment, the presently disclosed methods and systems relieveedema in and around the optic nerve head by creating a cerebrospinalfluid filter from the SAS of the optic nerve into the surroundingorbital tissue, thereby reducing the cerebrospinal fluid volume andpressure surrounding the optic nerve head. In another embodiment, thepresently disclosed methods and systems increase a velocity ofcerebrospinal fluid in the optic nerve sheath, thereby leading to adecrease in cerebrospinal fluid pressure communicated to the optic nervehead. In another embodiment, the presently disclosed methods and systemspromote increased fibrous tissue proliferation at the incisional site,thereby preventing the transmission of elevated cerebrospinal fluidpressure to the optic nerve head. In various embodiments the methoddescribed in the present specification may be used for treatingdiseases/conditions such as but not limited to primary and secondary CNSmalignancies, primary and secondary CNS bacterial and non-bacterialinfections, and autoimmune diseases which require immunosuppressivetherapy.

The method of the present specification may also be used to treatconditions related to elevated intracranial pressure, including but notlimited to, idiopathic intracranial hypertension (IIH), higherelevations/space travel induced vision impairment and intracranialpressure (VIIP), and intracranial space occupying lesions such as butnot limited to tumor, blood, foreign body, swelling, inflammation, andinfection. In various embodiments, the method of the presentspecification may also be used to treat conditions related to elevatedintraocular pressure, including but not limited to, primary open angleglaucoma, normal tension, and low tension glaucoma, ocular hypertension,primary closed angle glaucoma, secondary angle closure glaucoma relatedto neo-vascular glaucoma, pigment dispersion syndrome, and uveiticglaucoma.

In an embodiment a surgical method is provided for deploying at leastone stent within an optic nerve sheath of a subject in order to treatIntracranial Hypertension (IH), relieve optic disc swelling, orotherwise treating papilledema.

FIG. 3A is a flow chart that describes a surgical process in accordancewith an embodiment of the present specification. At 302, a conjunctivalaccess is created. In an embodiment, a medial peritomy is performed in adirection of 12 to 6 'o clock. The peritomy involves a surgical incisionof the conjunctiva and subconjunctival tissue about the circumference ofa cornea. In another embodiment, a small conjunctival incision isperformed, avoiding a full peritomy.

At 304, a blunt dissection is performed with Westcott scissors in orderto bare sclera. Sclera is the tough, white outer coat of the eyeball,which covers approximately the posterior five-sixths of its surface,continuous anteriorly with the cornea and posteriorly with the externalsheath of the optic nerve. At 306, the medial rectus (MR) muscle isisolated but, unlike the prior art, is preferably not removed ordetached. Rather, a minimally invasive applier, such as an endoscopewith optical visualization and a curved distal end, is used to trackalong the wall of the eye to reach the optic nerve without the need fora significant abduction or reversion of the eyeball and thereby notrequiring the medial rectus muscle to be removed. In a less preferredembodiment, the MR muscle is detached from the globe using scissors,leaving a small remnant of muscle tendon attached to the globe. Such adetachment may facilitate further visualization, for example in caseswhere endoscopic approach is unavailable.

At 308, a viscoelastic is injected between sclera and Tenon's capsule.In embodiments, the viscoelastic functions as a spacer between thesclera and the Tenon's capsule. In embodiments, the viscoelastic alsopreserves vasculature during subsequent possible placement of anendoscope for visualization and navigation to a retro-orbital nerve. Inalternative embodiments, a fluid may be infused or irrigated through theoptic nerve sheath for gentle visco-dissection of the sheath without theinjection of a viscoelastic material.

At 310, a micro dissecting retractor or forceps is used to identify theoptic nerve. Additionally, an insertion site is identified on the opticnerve. In embodiments, a site at a distance of about 2 mm from the globeis identified for insertion. At 312, one or more stents (or shunts) areinserted in to the optic nerve sheath at the site identified in theprevious step. In embodiments, the one or more stents are inserted atleast 1 mm posterior to the optic nerve, preferably in the range of 1.5mm to 3 mm. In an embodiment, the stents vary in length. In anembodiment, the length of stents may be between 3-6 mm. In accordancewith an aspect, at 312 a depot stent-type drug delivery device isinserted in to the optic nerve sheath at the site identified in step310.

At 314, an inspection is performed at the insertion site to check forfluid egress in to retro-orbital fat. In an embodiment, the surgicalprocess is guided with fluorescence imaging to identify fluid flow, andtherefore identify fluid egress in to the retro-orbital fat.

Subsequently, at 316, any viscoelastic is removed by aspiration with theuse of a micro-aspiration unit.

Stent/Shunt

FIG. 4A shows a stent or shunt 400 a, in accordance with an embodimentof the present specification. In a preferred embodiment, the stent 500 ashown in FIG. 4A is inserted in to the optic nerve sheath at theidentified site as described at step 312 of FIG. 3A above. The stent orshunt 400 a is an elongate member having a proximal end 410, a distalend 415, and at least one element or structure that permits fluid (suchas aqueous humour) to flow along the length of the shunt 400 a such asthrough the shunt 400 a and/or around the shunt 400 a. In accordancewith aspects of the present specification, the stent or shunt 400 acomprises at least one internal lumen 405 having at least one openingfor ingress of fluid and at least one opening for egress of fluid. Inthe embodiment of FIG. 4A, the shunt 400 a includes a single opening 406at the proximal end 410 and a single opening 407 at the distal end 415that both communicate with the internal lumen 405.

FIG. 4B shows a stent or shunt 400 b, in accordance with anotherembodiment of the present specification. In this embodiment, the stentor shunt 400 b comprises a plurality of openings or pores 430 thatcommunicate with an internal lumen 435. The internal lumen 435 runsalong a length of the stent 400 b from an opening 440 at a proximal end442 to an opening 445 at a distal end 447. In this embodiment, theplurality of openings or pores 430 function as channels for flow offluid in addition to the internal lumen 435. In alternate embodiments,the plurality of openings 430 may be configured as fenestrations, slitsor slots, for example.

Referring now to FIGS. 4A and 4B simultaneously, the internal lumens405, 435 serve as passageway for the flow of aqueous humour through theshunts 400 a, 400 b from an anterior chamber to a suprachoroidal space.In addition, the internal lumens 405, 435 are used to mount the shunts400 a, 400 b onto a delivery system. The internal lumens 405, 435 canalso be used as a pathway for flowing irrigation fluid into the eyegenerally for flushing or to maintain pressure in the anterior chamber.In the embodiments of FIGS. 4A, 4B the shunts 400 a, 400 b have asubstantially uniform diameter along their entire lengths; however, inalternate embodiments, the diameter of the shunts can vary along itslength. Still alternately, although the shunts 400 a, 400 b are shown ashaving circular cross-sectional shapes, the shunts can have variouscross-sectional shapes (such as, but not limited to, an oval, square orrectangular cross-sectional shape) and can vary in cross-sectional shapemoving along their lengths. In some embodiments, as illustrated in thestent or shunt 400 a, at least one positioning marker or aid 420 isprovided, such as near the proximal end 410, to provide sensory feedbackto the user for real-time placement of the shunt, confirmation ofplacement of the shunt and/or during patient follow-up post implantationof the shunt. In various embodiments, the marker or aid 420 may bevisual, tomographic, echogenic, or radiopaque.

In some embodiments, as illustrated in the stent or shunt 400 b, atleast one retaining element 450 is provided, such as near the proximalend 442, to enable anchoring the implanted stent 400 b. In variousembodiments, the retaining element 450 comprises one or more retentionelements such as, but not limited to, protrusions, ridges, rings, wings,tines, or prongs, that lodge into anatomy to retain the shunt in place(that is, to prevent migration of the shunt) and to ensure communicationbetween the space below the optic nerve sheath and the retrobulbarspace. In various embodiments, the retention elements comprise extensionplates, pedicles, finger-extensions and other structures at the contactinterface with the optic nerve. In some embodiments, the retainingelement 450 is flexible or deformable and can be made from biocompatiblematerials such as, but not limited to, polyamide or silicone elastomer.In some embodiments, the retaining element 450 is stiff and made frommaterials such as, but not limited to, stainless steel or Nitinol. Invarious embodiments, the retaining element 450 vary in shape such as,but not limited to, barb-shaped, ring or round shaped, rectangular,triangular or any combinations thereof. It should be appreciated that insome embodiments a stent or stunt may comprise a combination of featuressuch as marker 420, retaining element 450 and the plurality of pores430.

In various embodiments, at least one stent or shunt (such as the stent400 a, 400 b) of a length that may vary between 0.3 millimeters (mm) and9 mm, is inserted in to the optic nerve sheath. In some embodiments, astent or shunt has a length in a range of 2 mm to 7 mm. In embodiments,the stent or shunt outer diameter does not exceed the diameter range ofa standard optical nerve, which is typically in a range of 5 to 6 mm.The stent or shunt may be inserted at a site that is at least 2 mmposterior to the optic nerve. In an embodiment, the stent or shunt hasan elongated tubular structure that has flexibility and is relativelyflat, such that its shape corresponds to that of the optical sheath thathas a lumen. In an embodiment, the length of the stent embedded withinan optic nerve sheath is less than or equal to 5 mm.

In an embodiment, the stent or shunt is J-shaped, L-shaped, or otherwisecurved at one end, such that the longer side is longitudinally placedwithin the optic sheath and the curved, shorter side maintains anopening to the outside. In an embodiment, the stent's structure mayinclude a long arm which extends parallel to the optic nerve under thesheath, and a curved end with an opening that goes through the sheath.In an embodiment, an external rim is placed around the opening at thecurved end in order to prevent sinking/migration of the stent below thenerve sheath. In an embodiment, the stent is an expandable longitudinalelement and/or memory shaped element comprising a mesh-like device whichassumes a different shape or larger internal diameter upon deployment.In embodiments, retention rings, ridges, or other retention features maybe provided with the stent, to keep it under the sheath. Additionally, aretention ring, a whisker, an extension, cap, or any other device may beprovided outside the sheath to keep it from migrating fully into theoptic nerve. In an embodiment, parts of the stent are fenestrated toaide in fluid flow.

In some embodiments, the stent or shunt is manufactured from a materialthat enables it to retain its size and shape permanently within theoptic nerve sheath until it is surgically removed. In some embodiments,the stent or shunt is manufactured using a bio-degradable material whilein alternate embodiments the stent or shunt is manufacture using anon-biodegradable material. In various embodiments, the stent or shuntcan be made of various materials, such as, for example, polyamide,Nitinol, platinum, stainless steel, molybdenum, or any other suitablepolymer, metal, metal alloy, or ceramic biocompatible material orcombinations thereof.

In embodiments, non-ferrous materials are preferred, as they are safefor MM (Magnetic Resonance Imaging) procedures. Other materials ofmanufacture or materials with which the shunt can be coated ormanufactured entirely include Silicone, PTFE, ePTFE, differentialfluoropolymer, FEP, FEP laminated into nodes of ePTFE, silver coatings(such as via a CVD process), gold, prolene/polyolefins, polypropylene,poly(methyl methacrylate) (PMMA), acrylic, Polyethylene Terephthalate(PET), Polyethylene (PE), PLLA, and parylene. The stent or shunt can bereinforced with polymer, Nitinol, or stainless steel braid or coiling orcan be a co-extruded or laminated tube with one or more materials thatprovide acceptable flexibility and hoop strength for adequate lumensupport and drainage through the lumen. The shunt can alternately bemanufactured of nylon (polyamide), PEEK, polysulfone, polyamide-imides(PAI), polyether block amides (Pebax), polyurethanes, thermoplasticelastomers (Kraton, etc.), and liquid crystal polymers. In oneembodiment, the stent or shunt is a heparin-coated, non-ferromagnetictitanium stent or shunt.

In embodiments, the stent or shunt can also be coated or layered with amaterial that expands outward once the shunt has been placed in the eye.The expanded material fills any voids that are positioned around theshunt. Such materials include, for example, hydrogels, foams,lyophilized collagen, or any material that gels, swells, or otherwiseexpands upon contact with body fluids.

In embodiments, the stent or shunt is an elongated tube or spacer,expandable or non-expandable, drug-eluting or non-drug eluting as may berequired for the range of clinical applications, rigid or flexible. Inembodiments, the stent or shunt may be used for delivering therapeutics.Along with retention features, the ability to expand as needed mayensure proper engagement of the stent or shunt in the tissue and createdesired outflow tract. In an embodiment, the stent or shunt includes avalve. In embodiment, the stent or shunt is used to deliver antibiotics,biologics, and other therapeutics for CNS delivery that may otherwisehave a low brain bioavailability when administered orally (PO) orthrough Intravenous (IV). Therapeutics positioned in a reservoir in thestent or shunt passively drains into a low pressure retrobulbar space.

In embodiments, the stent or shunt is optionally combined with one ormore sensors. In some embodiments, one or more sensors are implantedwithout the stent or shunt. The optional sensors (with or without thestent or shunt) may be used to monitor flow rates, pressure, and otherparameters that may be monitored from the location of the stent withinthe optic nerve sheath. In an embodiment, a micro sensor is implantedfor eye pressure measurement, the micro sensor comprising a MEMS sensoror sensors with a power source that is not local to the sensor. Sensorsmay help monitoring the surgical procedure as well as may be deployedwith the stent to monitor the subject regularly for pressure variations.The sensors may communicate with external handheld or other devices fortransfer and analysis of measurement data. A smartphone-app may beintegrated in the communication system to connect the patient, thedoctor, a central database, or any other entity.

FIG. 5A illustrates a stent or shunt 505 carrying an optional sensor 510in accordance with an embodiment of the present specification. In FIG.5A, an eyeball 504 is depicted with the stent or shunt 505 (the stent orshunts 400 a, 400 b of FIGS. 4A, 4B respectively) shown positionedwithin the optic nerve sheath 525. At least one sensor 510 is located atan ingress tip 515 of the stent or shunt 505 such that the at least onesensor 510 lies within the sheath 525—specifically, the subarachnoidspace. In some embodiments, the at least one sensor 510 is a MEMS sensorconfigured to measure intracranial pressure and/or to monitor flowrates. The stent or shunt 505 enables fluid (such as aqueous humour) toflow from at least one opening at the ingress tip 515 to an egress tip516 via at least one internal lumen along the length of the shunt 505.An opening 517 is included in the egress tip 516 and is in fluidcommunication with the internal lumen. In embodiments, additional fluidflow is enabled through a plurality of fenestrations or pores 520 thatcommunicate with the internal lumen.

FIG. 5B illustrates an embodiment showing an eyeball 504 where a sensor530 (without a stent or shunt) is positioned within the optic nervesheath 525 so as to lie within the subarachnoid space. In embodiments,the sensor 530 is mounted on a first end 536 of a base member 535. Thebase member 535 comprises a retention feature 537, such as a collar, ata second end 538 to retain the base member 535 and hence the sensor 530in position within the sheath 525.

Drug Delivery Method and Device

Referring back to FIG. 3A, in accordance with another aspect of thepresent specification, at step 312 a depot stent-type drug deliverydevice is implanted in to the optic nerve sheath at the site identifiedin step 310. FIG. 3B illustrates a stent-type drug delivery deviceimplanted into the optic nerve sheath, in accordance with an embodimentof the present specification. As shown, a depot stent-type drug deliverydevice 320 is a valved or flow-restrictive device that allowsunidirectional flow of therapeutic drugs from a refillable reservoir 322or chamber to the CSF 324 or a subconjunctival space of an eyeball 326via an outlet tube 328 in fluid communication with the reservoir 322.

FIG. 6A shows a perspective view of a drug delivery device or valve 600while FIG. 6B shows an exploded view of the device 600 in accordancewith an embodiment. The device or valve 600 comprises a base plate 605,a flexible membrane 610 (such as that of siliconized rubber), a coverplate 620 and a flexible outlet tube 625 (such as that of siliconizedrubber). The membrane 610 is folded to form a valve comprising a pair ofmembrane members 610 a and 610 b defining a chamber there-between. Arear portion of the base plate 605 is surrounded by a ridge 640 to forma reservoir 645 to store a prescribed quantity of drug. The membranemembers 610 a and 610 b are placed between the plates 605, 620 and theseplates are pressed together and interlocked to hold the membrane membersin position. The outlet tube 625 (having a lumen) extends from theplates 605, 620 and the membrane 610 so that its free end 630 maydeliver metered doses of the drug, stored in the reservoir 645, into theCSF. In embodiments, the reservoir 645 allows sustained release of atleast one drug in a range from 1 to 360 days as therapeuticallyindicated. In accordance with aspects of the present specification, thereservoir 645 is a refillable subconjunctival, subtenon or otherocular/extra ocular reservoir that, in various embodiments, is connectedinto the extended optic nerve subdural space and can be charged orrefilled for a plurality of drug administrations and dosing regimens.The reservoir 645 is either fixed or adjacent to the sclera for easyaccess to enable refills. In an embodiment, the reservoir has a capacityless than or equal to 700 mm³

In accordance with aspects of the present specification, the outlet tube625 includes a unidirectional valve 650 for allowing the drug to flowtowards the eye under low pressure gradient conditions and preventingretrograde flow back towards the membrane 610 and reservoir 645. In anembodiment, as shown in FIG. 6C, the unidirectional valve 650 is formedin a “wet straw” configuration where a generally circular cross-section652 is drawn to a flattened end 654. With this configuration, a positivepressure gradient serves to open the “wet straw” to allow fluid to flowin the direction of the arrow 655, whereas a negative pressure gradientwill cause valve 650 to collapse on itself to prevent retrograde flow.Because of its pliability and its low frictional properties, TEFLON(polytetrafluoroethylene) is a suitable material for the construction ofvalve 650, although other materials may be found to functionsatisfactorily.

In some embodiments, the plates 605, 620 are substantially rectangularwith curved corners and have a length of 16.0 mm, a breadth of 13.0 mm,a thickness of 2.1 mm and a surface area of 184.0 mm². In embodiments,the outlet tube 625 is about 25.4 mm long, has an outer diameter of0.635 mm and an inner diameter of 0.305 mm.

FIG. 6D is a flowchart illustrating a method of surgical implantation ofthe drug delivery device 600, in accordance with an embodiment of thepresent specification. At step 670, a conjunctival access is created inthe patient's eye. In another embodiment, a small conjunctival incisionis performed, avoiding a full peritomy, and the sclera of the eye isbared. At step 672, a minimally invasive applier, such as an endoscopewith visualization and a curved distal end, is used to track along thewall of the eye to reach the optic nerve without the need for asignificant abduction or reversion of the eyeball and thereby notrequiring the medial rectus muscle to be removed. In an embodiment, aviscoelastic may injected between sclera and Tenon's capsule. Inalternative embodiments, a fluid may be infused or irrigated through theoptic nerve sheath for gentle visco-dissection of the sheath without theinjection of a viscoelastic material. At step 674, a micro dissectingretractor or forceps is used to identify the optic nerve, and aninsertion site is identified on the optic nerve. At step 676, the drugdelivery device is inserted in to the optic nerve sheath at the siteidentified in the previous step. At step 678, the therapeutic agent fromthe reservoir of the drug delivery device is delivered into theinsertion site via the outlet tube of the device.

The drug delivery device 600 and its implantation using the surgicalmethod of FIG. 3A enable continuous delivery of drugs, such asanalgesics (for pain management), anti-cancer drugs, antibiotics,neurologic related spasticity drugs, and other therapeutics that requiredrug delivery via cerebral spinal fluid such as for, but not limited to,intrathecal chemotherapy. Thus, the drug delivery device 600 enablesdelivery of drugs for treatment of a plurality of central nervous systemdiseases including, but not limited to, oncologic, infectious and immunediseases, where delivery of therapeutic agents into the CSF and the CNSis essential. In various embodiments, the therapeutics or drugs areeither small or large molecules such as, but not limited to,antibiotics, chemotherapeutic agents and other biologics known topersons of ordinary skill in the art. Exemplary anti-cancer compositionsinclude cisplatin, cetuximab, carboplatin cisplatinum, platamine,neoplatin, cismaplat, docetaxel, paclitaxel, and methotrexate.

The following are an examples of dosing regimens for any primary orsecondary cancers: Use Case—Leptomeningeal Metastasis of tumors, suchas, but not limited to, Gliomas, Melanoma, Breast, Lung, Lymphoma,Leukemia, Prostate, Testicular, Ovarian, Pancreatic, and tumors.

Current Treatment—Single medication or combination of medications suchas, but not limited to, Methotrexate, Cytarabine, Hydrocortisone, andThiotepa.

Dosage and Regimen—Given the reservoir and the ability to have atime-sensitive and sustained dosing (which could help with side effectsrelated to the above medications), dosage and regimen vary based on theweight of the patient and type of tumor. For example, for Leptomeningealspread from Lymphoma the following treatment regimen is followed:

BCCA administration Drug Dose Guideline Methotrexate 12 mg on days 1, 8and 15 Intrathecal qs to 6 mL with preservative-free NS Cytarabine 50 mgon days 4, 11 and 18 Intrathecal qs to 6 mL with preservative-free NS

In another non-limiting use case, the reservoir 645 enablesadministering of therapeutics for elevated intracranial pressure (ICP),such as resulting from space travel, for example. In embodiments, thereservoir 645 delivers Diamox in a sustained dosing (such as, 250milligram to 500 milligram orally, twice daily) to prevent optic discedema and symptoms related to elevated ICP, such as transient visualobscurations, headaches, tinnitus, vertigo and double vision.

Delivery Apparatus/Applicator

In embodiments, an applicator is used to deploy the stent or the shunt.In an embodiment, the applicator (or applier) comprises viewingapparatus such as an endoscopic camera. In an embodiment, the applierhas a curved configuration that may enable the applier to move along thewall of the eye in order to reach the optic nerve during the surgicalprocedure. The curved configuration may also enable access to the opticnerve without need for significant abduction/eversion of the eyeball,and thus may not require removal of medial rectus muscle.

In an embodiment, use of an endoscopic applier to deploy the stent maycurb the need of a viscoelastic or any other fluid which is otherwiseinjected between the sclera and the Tenon's capsule.

FIG. 7 is an exemplary applicator or delivery system 700, in accordancewith an embodiment of the present specification, that can be used todeliver or implant a stent or shunt 705 (such as the stents or shunts400 a, 400 b of FIGS. 4A, 4B respectively). The delivery system 700comprises a handle portion 715 and a delivery portion 720 that may beremovably coupled to the shunt 705 for delivery or implantation of theshunt 705 into an eye. The delivery portion 720 includes an elongateapplier or guidewire 725 which may be curved or non-curved. The applieror guidewire 725 is sized to fit through the lumen of the shunt 705 suchthat the shunt 705 can be mounted on the applier 725. In variousembodiments, the applier 725 has a cross-sectional shape thatcomplements the cross-sectional shape of the internal lumen of the shunt705 to facilitate mounting of the shunt onto the applier 725. In someembodiments, the applier 725 has a sharpened distal tip 722. Inalternate embodiments, the applier 725 can have an atraumatic or bluntdistal tip 722 such that it serves as a component for coupling to theshunt, or performing blunt dissection, rather than as a cutting element.In still alternate embodiments, the delivery portion 720 does notinclude a guidewire.

The delivery portion 720 also includes a shunt deployment or advancingelement 730 positioned on a proximal end 723 of the applier 725. In someembodiments, the advancing element 730 is an elongated tube that ispositioned over the applier 725. The delivery system 700 is actuated toachieve relative, sliding movement between the advancing element 730 andthe applier 725. In embodiments, the advancing element 630 is moved inthe distal direction, while the applier 725 remains stationary to pushor otherwise advance the shunt 705 along the applier 725 for delivery ofthe shunt 705 into the eye. In an alternate embodiment, the applier 725withdraws into the advancing element 730 to remove the shunt 705 fromthe applier 725. In yet another embodiment, both the advancing element730 and the applier 725 move relative to one another to remove the shunt705.

In an embodiment, the applier 725 has a length sufficient to receive aplurality of shunts in an end-to-end series arrangement on the applier725. In this embodiment, plurality of shunts 705 can be loaded onto theapplier 725 and implanted one at a time such that the shuntscollectively form an elongated lumen of sufficient length for adequatedrainage of aqueous humour. This allows relatively short length shuntsthat can be collectively used in various eye sizes.

The handle portion 715 is actuated to control delivery of the shunt 705.In embodiments, the handle portion 715 includes an applier or guidewireextension button 740 that is actuated to cause the applier or guidewire725 to extend in length in the distal direction. In embodiments, thehandle portion 715 includes an applier or guidewire retraction button745 that is actuated to cause the applier or guidewire 725 to retract inlength in the proximal direction. In some embodiments, the handleportion 715 also includes a shunt advancing actuator 735 that can beactuated to selectively move the advancing element 730 along the applier725—in the proximal or distal direction. Using the actuator 735, theadvancing element 730 can be used to push the shunt 705 in the distaldirection and off of the applier 725 during delivery, or else to holdthe shunt 705 in a fixed location in the eye while the applier 725 iswithdrawn.

In some embodiments, the applier 725 passes through the conjunctiva toaccess the retrobulbar space of a subject and implants the stent orshunt 705 through the optical sheath. In other embodiments, the applier725 passes through Tenon's, or any other part within the anatomy of theeye that allows access to the retrobulbar space.

In various embodiments, the applier or guidewire 725 can be straight orthe applier 725 can be curved along all or a portion of its length, suchas at the distal tip 722 (as shown in FIG. 7) in order to facilitateproper placement through the cornea. The curved configuration may alsoenable access to the optic nerve without need for significantabduction/eversion of the eyeball, and thus may not require removal ofmedial rectus muscle. Accordingly, the curvature of the applier 725 canvary. For example, the applier 725 can have a radius of curvature of 3mm to 50 mm and the curve can cover from up to 180 degrees in variousembodiments. In one embodiment, the applier 725 has a radius ofcurvature that corresponds to or complements the radius of curvature ofa region of the eye, such as the suprachoroidal space.

In various embodiments, the system 700 is an endoscopic applicatorwherein the handle portion 715 or the delivery portion 720 (such as theguidewire 725 or the shunt deployment or advancing element 730)comprises one or more illumination elements, such as LEDs (LightEmitting Diodes) and at least one endoscopic viewing element, such as acamera, for posterior visualization in the orbit. In some embodiments,use of an endoscopic applicator to deploy the stent may curb the need ofa viscoelastic fluid or any other fluid which is otherwise injectedbetween the sclera and Tenon's capsule. However, in alternateembodiments, the system 700 may use a viscoelastic fluid or any otherfluid for irrigation, such as, through the guidewire 725.

The above examples are merely illustrative of the many applications ofthe system of present specification. Although only a few embodiments ofthe present specification have been described herein, it should beunderstood that the present specification might be embodied in manyother specific forms without departing from the spirit or scope of thespecification. For example, while the presently disclosed specificationsare indicated to treat papilledema due to intracranial hypertension,they may also be employed to treat cases of papilledema with impendingor progressive visual loss due to an unresectable central nervous systemmass, an arteriovascular malformation of the vein of Galen, venous sinusthrombosis, cryptococcal meningitis, and obstruction of the cerebralvenous system from a compressive lesion. Therefore, the present examplesand embodiments are to be considered as illustrative and notrestrictive, and the specification may be modified within the scope ofthe appended claims.

We claim:
 1. A surgical method for treating at least one of intracranialhypertension and papilledema in a patient, comprising: navigating anapplier device along a curvature of an eye of the patient withoutremoving a medial rectus muscle associated with said eye; injecting aviscoelastic between the sclera of said eye and a Tenon's capsuleassociated with said eye; inserting at least one stent into an opticnerve sheath associated with the eye; observing an amount of fluidegress from the at least one stent; and removing the viscoelastic. 2.The method of claim 1 further comprising creating a conjunctival accessbehind said eye.
 3. The method of claim 2 comprising performing at leastone of a medial peritomy on said eye prior to injecting saidviscoelastic and a conjunctival incision on said eye prior to injectingsaid viscoelastic.
 4. The method of claim 3, wherein the medial peritomyis performed in a direction from 12 o'clock to 6 o'clock.
 5. The methodof claim 2 comprising performing a conjunctival incision.
 6. The methodof claim 1 further comprising dissecting bluntly to bare the scleraprior to injecting said viscoelastic.
 7. The method of claim 6, whereinthe dissecting is performed with Westcott scissors.
 8. The method ofclaim 1 further comprising isolating the medial rectus muscle prior toinjecting said viscoelastic.
 9. The method of claim 1 further comprisingidentifying an insertion site on an optic nerve associated with the eye.10. The method of claim 9 wherein the insertion site is at a distance ofat least 1.5 mm from a globe of said eye.
 11. The method of claim 9comprising inserting the at least one stent at the insertion site,wherein said insertion site is at least 1.5 mm posterior to the opticnerve.
 12. The method of claim 1 comprising inserting the at least onestent having a length between 3 mm and 6 mm.
 13. The method of claim 12comprising inserting the at least one stent having a diameter of 6 mm orless.
 14. The method of claim 1 wherein the at least one stent comprisesmaterial with properties that are a combination of one or more of:bio-degradable, heparin-coated, non-ferromagnetic Titanium, polyamide,super-elastic, bio-compatible, an alloy of Nickel-Titanium, rigid,flexible, expandable, and non-expandable.
 15. The method of claim 1wherein the at least one stent has as an elongated tube.
 16. The methodof claim 15 wherein the at least one stent has a flat structure.
 17. Themethod of claim 1 wherein the at least one stent shaped is J shaped,wherein a longer side of the J-shaped stent is longitudinally placedwithin the optic nerve sheath, and wherein the curved, shorter sidemaintains an opening to an outside of said optic nerve sheath.
 18. Themethod of claim 1 wherein the at least one stent further comprises oneor more sensors.
 19. The method of claim 1 wherein the at least onestent further comprises one or more therapeutic compositions.
 20. Themethod of claim 1 further comprising inspecting the site of insertingfor fluid egress.